Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202312806863861 Date of Approval: 14/12/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A comparison of the efficacy of combined intramuscular Pentazocine and Diclofenac versus Bupivacaine Infiltration and intramuscular Diclofenac, for post Caesarean analgesia in Federal Medical Centre, Gusau: A Randomized Controlled Trial.
Official scientific title A comparison of the efficacy of combined intramuscular Pentazocine and Diclofenac versus Bupivacaine Infiltration and intramuscular Diclofenac, for post Caesarean analgesia in Federal Medical Centre, Gusau: A Randomized Controlled Trial.
Brief summary describing the background and objectives of the trial Background: Caesarean section is one of the most commonly performed operations in obstetric practice. Multimodal approach to post caesarean pain management has been shown to be more effective than unimodal approach. However, the most effective combination and preferred route of administration are still under study. Objective: To compare efficacy of combined intramuscular Pentazocine and Diclofenac versus combined Bupivacaine wound infiltration and intramuscular Diclofenac after Caesarean section at Federal Medical Centre, Gusau.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Caesarean section
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/02/2022
Actual trial start date 01/10/2022
Anticipated date of last follow up 30/07/2022
Actual Last follow-up date 30/03/2023
Anticipated target sample size (number of participants) 170
Actual target sample size (number of participants) 170
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Combined Intramuscular Pentazocine and Diclofenac. Methodology: This is a double blinded, randomized controlled trial in which 170 booked consenting women scheduled for elective caesarean section at the Maternity Unit of Federal Medical Centre, Gusau over a period of five (5) months and who have satisfied the inclusion criteria will be recruited and assigned to the randomly allocated study(S) or control groups(C). All caesarean sections will be performed under spinal anaesthesia. The study(S) group will receive 20mls 0.25% of plain Bupivacaine for subcutaneous wound infiltration before subcutaneous and skin wound closure while the control (C) will receive 20mls of Placebo for wound infiltration during the same period. Each group will subsequently be given analgesia according to study protocol for 24hours as follow: In the study(S) group, this will be followed by 75mg of intramuscular Diclofenac 8hourly and 2mls of Placebo 6 hourly starting 1hours from the end of the surgery for 24 hours while the control group will receive 75mg of intramuscular Diclofenac 8hourly and 2mls (60mg) of intramuscular Pentazocine 6hourly during the same period. The primary outcome include pain perception at 1hour, 2hours, 6hours, 12hours and 24hours which will be assessed by Visual Analogue Scoring Scale. Secondary outcomes include total amount of rescue analgesia given, maternal satisfaction, side effects or complications on mother, wound infection and hematoma will be compared between the two groups at 72 hours. 5 MONTHS The control (C) will receive 20mls of Placebo for wound infiltration during the same period. The group will subsequently be given analgesia according to study protocol for 24hours as follow: In the study(S) group, the control group will receive 75mg of intramuscular Diclofenac 8hourly and 2mls (60mg) of intramuscular Pentazocine 6hourly during the same period. The primary outcome include pain perception at 1hour, 2hours, 6hours, 12hours and 24hours which will be assessed by Visual Analogue Scoring Scale. Secondary outcomes include total amount of rescue analgesia given, maternal satisfaction, side effects or complications on mother, wound infection and hematoma will be compared between the intervention and the controlled groups at 72 hours. 170 Active-Treatment of Control Group
Experimental Group bupivacaine wound infiltration and intramuscular diclofenac The study(S) group will receive 20mls 0.25% of plain Bupivacaine for subcutaneous wound infiltration before subcutaneous and skin wound closure while the control (C) will receive 20mls of Placebo for wound infiltration during the same period. 5 months Each group will subsequently be given analgesia according to study protocol for 24hours as follow: In the study(S) group, this will be followed by 75mg of intramuscular Diclofenac 8hourly and 2mls of Placebo 6 hourly starting 1hours from the end of the surgery for 24 hours. The primary outcome include pain perception at 1hour, 2hours, 6hours, 12hours and 24hours which will be assessed by Visual Analogue Scoring Scale. Secondary outcomes include total amount of rescue analgesia given, maternal satisfaction, side effects or complications on mother, wound infection and hematoma will be compared between the two groups at 72 hours. 170
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women planned for elective caesarean section under spinal anaesthesia regardless of number of previous caesarean sections who consents to participate in the study after proper and appropriate counselling. 1.Patients that are not able to understand or to use VAS(mentally retarded, psychiatric disorder) 2.Patient that undergoes caesarean section under general anaesthesia 3.Patients with proven or suspected allergy to local anaesthetics 4.Patients with proven or suspected allergy to Pentazocine or Diclofenac. 5.Patients chronically (more than 2 weeks) treated with Opioids medications. 6.Patients that are Opioids dependent or addicted ( determine by their previous experience with Opioids) 7.Patient with sickle cell disease or with uncontrollable diabetic mellitus. 8.Patients with chronic medical condition such as cardiovascular, hepatic or renal insufficiency 9.Booked pregnant women that did not consent 10.All emergencies or complicated caesarean sections such as obstructed labour, foetal distress, prolonged labour etc. 11.Patients with Intrauterine foetal death or Major foetal malformation Adult: 19 Year-44 Year 19 Year(s) 44 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/05/2021 Health Research and Ethic Committee
Ethics Committee Address
Street address City Postal code Country
Federal Medical Centre, Gusau. Sokoto Bye-Pass Road Gusau pmb01008 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare the efficacy of Bupivacaine local wound infiltration and intramuscular Diclofenac with combined intramuscular Pentazocine and Diclofenac, as post caesarean section analgesia. 0 hour, 1hour, 2hr, 6hour, 12hour and 24 hour
Secondary Outcome . To compare rate of use of rescue analgesia between the study population and the control. OVER 24 HOURS
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical centre Gusau Sokoto Bye-Pass Road, Gusau PMB01008 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Sponsor Federal Medical Centre, Gusau. Sokoto Bye Pass Gusau PMB01008 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor PRIMARY RESEARCHER sokoto Bye Pass, Gusau Gusau PMB01008 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adelakun Muyideen Bimbo adelakmsurgeon@gmail.com 08065345986 Sokoto Bye Pass
City Postal code Country Position/Affiliation
Gusau PMB01008 Nigeria Senior Registrar in Obstetrics and Gynaecology Department
Role Name Email Phone Street address
Public Enquiries Abubakar Danladi danabu99@gmail.com 08030673260 Sokoto Bye Pass
City Postal code Country Position/Affiliation
Gusau PMB01008 Nigeria Obstetrics and Gynaecology Department
Role Name Email Phone Street address
Scientific Enquiries Mohammed Abdul maabdul90@gmail.com 08035889959 Sokoto Bye Pass
City Postal code Country Position/Affiliation
Gusau PMB01008 Nigeria Obstetrics and Gynaecology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes, the individual data will be available( including data dictionaries). All the individual participants data collected during trial and after deidentification. study protocol, statistical analysis plan and consent form will be available. Data will be immediately following publication and ending 3years. it will be access by anyone. the data will be analysed to achieved the aims in the approved proposal. the result/data will be published in Tropical Journal of Obtetrics and Gynaecology following acceptation. data are available indefinitely on; mailto:info@fmcgusau.gov.ng Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication and ending 3years The result/data will be published in Tropical Journal of Obtetrics and Gynaecology following acceptation. data are available indefinitely on; mailto:info@fmcgusau.gov.ng
URL Results Available Results Summary Result Posting Date First Journal Publication Date
mailto:info@fmcgusau.gov.ng No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information